A Study in Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT01125358

Recruitment Status
:
Terminated
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)

Change from baseline up to 7 week endpoint in the Positive and Negative Syndrome Scale (PANSS) total score, positive score, negative score, and psychopathology subscale [ Time Frame: Baseline, up to 7 weeks ]

Change from baseline up to 7 week endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, up to 7weeks ]

The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to 9 weeks ]

Rate of discontinuation [ Time Frame: Through 7 weeks ]

Original Secondary Outcome Measures ICMJE (submitted: May 17, 2010)

Change from baseline up to 7 week endpoint in the Positive and Negative Syndrome Scale (PANSS) total score, positive score, negative score, and psychopathology subscale [ Time Frame: Baseline, up to 7 weeks ]

Change from baseline up to 7 week endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint on the MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, up to 7weeks ]

The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to 9 weeks ]

Change from baseline up to 7 week endpoint on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint in Resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint on functional capacity, as measured by UCSD Performance-based Skills Assessment - Brief Version (UPSA-B) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [ Time Frame: Baseline, up to 7weeks ]

Change from baseline up to 7 week endpoint in the Personal and Social Performance (PSP) score [ Time Frame: Baseline, up to 7weeks ]

Rate of discontinuation [ Time Frame: Through 7 weeks ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

A Study in Schizophrenic Patients

Official Title ICMJE

A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia

Brief Summary

This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.

Non pregnant female patients who agree to use acceptable birth control

At entry to the study must be considered moderately ill in the opinion of the investigator

1 year history of Schizophrenia prior to entering the study

At study entry patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study based on the investigator's clinical judgment. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization

At study entry patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years

At study entry patients must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study

Exclusion Criteria:

Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1

Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity

Have any known history of receiving treatment with clozapine at any dose, as determined at baseline

Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study

Patients who are currently suicidal

Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study

Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years

Patients are excluded if their, biological father, mother, brother, sister, or child has a history of idiopathic epilepsy

Within 1 year of study enrollment, patients have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive

Patients are excluded if they have a lifetime history of any of the following:

head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);

brain surgery;

an electroencephalogram with paroxysmal (epileptiform) activity, or

brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome

Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study